FDA Orange Book · active-ingredient family
Ivermectin
Ivermectin: 3 brands, 12 generics; first approved Nov 22, 1996; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 12 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
12
Listed patents
5
Next patent expiry
Mar 13, 2034
in 7 yr 6 mo
Brand (NDA) products
Originator applications
- GALDERMA LABS LPNDA 2062552014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% CREAM TOPICAL Rx AB - ARBOR PHARMS LLCNDA 2027362012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% LOTION TOPICAL OTC — - MERCK SHARP DOHMENDA 05074219982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG TABLET ORAL Discontinued — 3MG TABLET ORAL Rx AB
Generic (ANDA) products (12)
Abbreviated applications
- IVERMECTINAJANTA PHARMA LTDANDA 2185092026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG TABLET ORAL Rx AB - IVERMECTINE5 PHARMAANDA 2168082026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG TABLET ORAL Rx AB - IVERMECTINZYDUS LIFESCIENCESANDA 2168632026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG TABLET ORAL Rx AB - IVERMECTINEPIC PHARMA LLCANDA 2188052025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG TABLET ORAL Rx AB - IVERMECTINRUBICON RESEARCHANDA 21592220252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG TABLET ORAL Rx AB 6MG TABLET ORAL Rx — - IVERMECTINSENORES PHARMSANDA 2183242024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG TABLET ORAL Rx AB - IVERMECTINZYDUS LIFESCIENCESANDA 2152102022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% CREAM TOPICAL Rx AB - IVERMECTINTEVA PHARMS USAANDA 2124852022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% LOTION TOPICAL Discontinued — - IVERMECTINTAROANDA 2107202020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% LOTION TOPICAL OTC — - IVERMECTINPADAGIS ISRAELANDA 2102252020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% CREAM TOPICAL Rx AB - IVERMECTINTEVA PHARMS USAANDA 2100192019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% CREAM TOPICAL Rx AB - IVERMECTINEDENBRIDGE PHARMSANDA 2041542014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9233118 | in 7 yr 6 mo | U-1631 | |
| 9089587 | in 7 yr 6 mo | U-1631 | |
| 9233117 | in 7 yr 6 mo | U-1631 | |
| 9782425 | in 7 yr 6 mo | U-1631 | |
| 10206939 | in 7 yr 6 mo | U-1631 |
Approval history
FDA approval span
First approval
30 yr 4 mo ago
Most recent approval
6 mo ago
Approvals span 1996–2026 across 15 FDA applications.
Brand (NDA) 320%
Generic (ANDA) 1280%
Ivermectin: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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